Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-01-30 @ 10:41 PM
Study NCT ID:
NCT03684759
Status:
COMPLETED
Last Update Posted:
2018-09-26
First Post:
2018-09-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sputum Validation for the Molecular Diagnosis of Respiratory Viral Infections in Cystic Fibrosis
Sponsor:
University Hospital, Brest
Organization:
Study Overview
Official Title:
Pilot Feasibility Study for Cystic Fibrosis Sputum Validation for the Molecular Diagnosis of Respiratory Viral Infections
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXPIRE
Brief Summary:
The aim of this pilot study is to demonstrate the feasibility of viral biomolecular diagnosis in sputum compared to nasopharyngeal swab in cystic fibrosis acute respiratory infection.
Detailed Description:
In cystic fibrosis (CF), patients face polymicrobial airway infections. Besides bacteria, viruses are now also considered as important agents in lung function deterioration. No strategy has been established on the optimal sampling for respiratory viral molecular diagnostic in CF. Nasopharyngeal swabs (NP) are recommended for respiratory viral screening in non-CF patients but are invasive and sometimes painful for patients. As sputa are non invasive and collected for bacterial monitoring in CF patients they could represent a convenient alternative to NP swabs.
This study's aim is to define whether viral screening give concordant results between sputa and NP swabs.
This study's aim is to define whether viral screening give concordant results between sputa and NP swabs.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: